PRO-CTCAE
Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events
In clinical trials, adverse symptom information is collected and reported by research staff, not directly by patients. Scientific evidence demonstrates health professionals underestimate the severity of symptoms compared to patients' own accounts. There is increased regulatory focus on use of patient-reported outcomes (PROs) for subjective domains such as adverse symptoms in clinical research. The PRO-CTCAE system has been developed by SemanticBits, under the sponsorship of the National Cancer Institute (NCI), to provide the cancer research community a electronic platform to improve the quality and efficiency of developing, administering, completing, managing, and analyzing symptom questionnaires used for patient reporting. The Problem
Research has demonstrated that the method used to solicit, assess, and document the symptoms reported by patients on clinical trials can significantly impact the quality, consistency, and usefulness of the data collected. A typical method of soliciting and documenting patient symptoms on a trial begins with a patient describing symptoms to a clinician, then the clinician interprets the patient's description and documents this interpretation in the patient's chart, after which a research associate reads and interprets chart and documents this interpretation on a study form. The data from this form is then entered into a study database where it will await analysis and assessment. The complex series of data transfers and interpretations in this process has been criticized as being error-prone, inefficient, and not reflective of the true patient experience during treatment.
The Solution
Patient self-reporting of adverse symptoms provides a more comprehensive and accurate picture of the patient's experience than the typical process described above. The PRO-CTCAE system is being developed by SemanticBits and the cancer research community, to provide an intuitive, web-based, scientifically validated mechanism for patient self-reporting of symptoms in clinical trials. The PRO-CTCAE system features:
- Form builder: create and manage PRO-CTCAE forms, define cycle based schedule and author rules for triggering alerts and notifications
- Simple patient interface: answer PRO-CTCAE forms, view responses
- Reporting and Analytics: generate drillable graphical and tabular patient and study level reports
- Rules-based alert notifications: configure rules based on pre-defined grade thresholds to trigger alert notifications
- Study management: manage study definition
- Study participant management: register and manage study participants
- Fine grained security and auditing: role-based and instance-level
- Admin interface: manage clinical and research staff
- Support for translation into multiple languages
- Includes both paper and electronic administration
- Integrated to complement the revised CTCAE (version 4.0)
- Meets caBIG compatibility standards and specifications
- An integrated item bank of clinician validated symptoms.
Benefits
Some of the key benefits that this systems offers are:
- Improve adverse symptom capturing, monitoring and reporting
- Simplifies the analysis of symptom data
- Fosters improved patient-clinician communication
- Minimizes the patient burden of symptom reporting with web-based survey accessibility, customizable survey length, and scientifically validated comprehension
- Improves data quality and consistency
- Reduces data entry burden of clinical staff
Technology
We heavily leverage industry standard open source technologies in the development of the PRO-CTCAE system. Some of key technologies include:
Spring Framework, JBoss Hibernate, JBoss Drools, JFreechart, Apache Formatting Objects Processor (FOP), Prototype, Scriptaculous, Direct Web Remoting (DWR), Apache Ant, Ivy, and Hudson.
Key Stakeholders
The PRO-CTCAE system is currently under active development through partnership with the cancer research community and under the specific leadership of the National Cancer Institute, Food and Drug Administration (FDA), Memorial Sloan Kettering Cancer Center, Duke Comprehensive Cancer Center, MD Anderson Cancer Center, and Dana-Farber Cancer Institute.
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